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EP0128683A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Single needle blood fractionation system having adjustable recirculation through filter

Assignee: Baxter International Inc
•
Filing: 1984-05-24
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Granted: —
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Expires: 2004-05-24
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Abstract

Abstract A single needle batch-type blood fractionation system for separating plasma from whole blood includes a disposable flow system having a single-lumen phlebotomy needle and associated donor conduit, a flow-through plasma separation filter, and an in-process fluid reservoir. During an initial draw cycle whole blood is pumped through the filter to the in-process reservoir by a peristaltic-type inlet pump operating at a predetermined draw rate. When a predetermined volume of filtered plasma-deficient blood has been collected in the reservoir, as sensed by the weight of the reservoir the system reverts to a return cycle wherein a portion of the plasma deficient blood in the reservoir is pumped back to the donor conduit by a peristaltic-type return pump operating at a predetermined return rate higher than the draw rate of the inlet pump. Depending on the relative operating speeds of the inlet and return pumps, an operator-controlfable portion of the plasma-deficient blood from the in-process reservoir is returned to the donor through the phlebotomy needle, and the remaining portion is recirculated through the filter. The partial recirculation of plasma-deficient blood through the filter during the return mode reduces the processing time of the system, provides for improved accommodation of whole blood of unusually high or low hematocrit, and enables the use of a smaller and less expensive filter.

Inventors

  • 👤 Arnold C. Bilstad
  • 👤 Richard I. Brown
  • 👤 Robert J. Kruger

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 13:24
CPC Classifications
A; A61; A61M; A61M1/00; A61M1/14; A61M1/30; A61M1/301; A61M1/303; A61M1/305; A61M1/308; A61M1/36; A61M1/3601; A61M1/3603; A61M1/3616; A61M5/00; A61M5/14; A61M5/168; A61M5/16831; A61M5/1684; A61M5/16845; A61M2205/00; A61M2205/33; A61M2205/3379; A61M2205/3382; A61M2205/3386

Claims Analysis

Total Claims: 58
Claim 1
Independent Claim 155 words
A blood fractionation system for separating a blood fraction from whole blood, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle for alternately drawing and returning whole blood from a donor; an intermediate fluid reservoir; separating means for separating the blood fraction from whole blood; first fluid conveyance means including an inlet pump for conveying fluid from said donor conduit through said separation means to said reservoir; second fluid conveyance means including a return pump responsive to the volume in said reservoir reaching a predetermined maximum level for conveying whole blood from said reservoir to said donor interface conduit to reduce the volume in said reservoir to a predetermined minimum level; and said second pump rate being set relative to said first pump rate whereby said operation of said second fluid conveyance means a selected portion of the flow from said reservoir is caused to recirculate through said separation means.
Claim 2
Dependent Claim 155 words
A blood fractionation system for separating a blood fraction from whole blood, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle for alternately drawing and returning whole blood from a donor; an intermediate fluid reservoir; separating means for separating the blood fraction from whole blood; first fluid conveyance means including an inlet pump for conveying fluid from said donor conduit through said separation means to said reservoir; second fluid conveyance means including a return pump responsive to the volume in said reservoir reaching a predetermined maximum level for conveying whole blood from said reservoir to said donor interface conduit to reduce the volume in said reservoir to a predetermined minimum level; and said second pump rate being set relative to said first pump rate whereby said operation of said second fluid conveyance means a selected portion of the flow from said reservoir is caused to recirculate through said separation means.
Claim 3
Dependent Claim 24 words
A blood fractionation system as defined in claim 1 wherein said second fluid conveyance means are responsive to the weight of said intermediate reservoir.
Claim 4
Dependent Claim 32 words
A blood fractionation system as defined in claim 2 wherein said second fluid conveyance means include a weight transducer for providing an output signal indicative of the weight of said intermediate reservoir.
Claim 5
Dependent Claim 36 words
A blood fractionation system as defined in claim 3 wherein said output signal is an analog signal and said second fluid conveyance means include means for comparing said signal with predetermined maximum and minimum reference levels.
Claim 6
Dependent Claim 20 words
A blood fractionation system as defined in claim 1 wherein the rates of said inlet and return pumps are operator-adjustable.
Claim 7
Dependent Claim 19 words
A blood fractionation system as defined in claim 1 wherein said inlet and return pumps are each peristaltic-type pumps.
Claim 8
Dependent Claim 42 words
A blood fractionation system as defined in claim 1 wherein the volume of said first fluid conveyance means is substantially equal to or greater than the volume of whole blood returned from said reservoir upon operation of said second fluid conveyance means.
Claim 9
Dependent Claim 54 words
A blood fractionation system as defined in claim 7 wherein said first fluid conveyance means include a fluid mixing chamber upline of said separation means having a volume substantially equal to or greater than the volume of whole blood returned from said reservoir upon a single operation of said second fluid conveyance means. 1
Claim 10
Dependent Claim 18 words
A blood fractionation system as defined in claim 1 wherein said separation means is a membrane type filter.
Claim 11
Dependent Claim 18 words
A blood fractionation system as defined in claim 9 wherein said filter is a hollow fiber type filter.
Claim 12
Dependent Claim 23 words
A blood fractionation system as defined in claim 1 wherein said second fluid conveyance means include a bubble trap and fluid absence detector.
Claim 13
Dependent Claim 222 words
A single needle blood fractionation system for separating a blood fraction from whole blood, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle and alternately operable in forward and reverse flow for alternately receiving and returning blood from a donor; an intermediate fluid reservoir; T means including a first conduit connecting said donor conduit to said intermediate fluid reservoir; means including a flow-through filter disposed in said first conduit for separating the desired blood fraction from whole blood flowing through said filter; means including a second conduit connecting said intermediate fluid reservoir and said donor interface conduit; an inlet pump for pumping fluid through said first conduit to said reservoir; a return pump for pumping fluid from said intermediate reservoir through said second conduit; system control means responsive to the volume of fluid in said intermediate reservoir for initiating operation of said return pump in response to said volume reaching a predetermined maximum level, and for terminating operation of said return pump upon said volume reaching a predetermined minimum level; and the rate of said return pump being adjustable relative to the rate of said inlet pump whereby upon operation of said return pump an operator selectable portion of the filtered blood in said second conduit is caused to recirculate through said first conduit and said filter.
Claim 14
Dependent Claim 222 words
A single needle blood fractionation system for separating a blood fraction from whole blood, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle and alternately operable in forward and reverse flow for alternately receiving and returning blood from a donor; an intermediate fluid reservoir; T means including a first conduit connecting said donor conduit to said intermediate fluid reservoir; means including a flow-through filter disposed in said first conduit for separating the desired blood fraction from whole blood flowing through said filter; means including a second conduit connecting said intermediate fluid reservoir and said donor interface conduit; an inlet pump for pumping fluid through said first conduit to said reservoir; a return pump for pumping fluid from said intermediate reservoir through said second conduit; system control means responsive to the volume of fluid in said intermediate reservoir for initiating operation of said return pump in response to said volume reaching a predetermined maximum level, and for terminating operation of said return pump upon said volume reaching a predetermined minimum level; and the rate of said return pump being adjustable relative to the rate of said inlet pump whereby upon operation of said return pump an operator selectable portion of the filtered blood in said second conduit is caused to recirculate through said first conduit and said filter.
Claim 15
Dependent Claim 23 words
A blood fractionation system as defined in claim 12 wherein said system control means are responsive to the weight of said intermediate reservoir.
Claim 16
Dependent Claim 30 words
A blood fractionation system as defined in claim 13 wherein said system control means include an electrical weight transducer providing an output signal indicative of the weight of said reservoir.
Claim 17
Dependent Claim 36 words
A blood fractionation system as defined in claim 14 wherein said output signal is an analog signal, and said system control means include means for comparing said output signal with predetermined maximum and minimum reference levels.
Claim 18
Dependent Claim 20 words
A blood fractionation system as defined in claim 12 wherein the rates of said inlet and return pumps are operator-adjustable.
Claim 19
Dependent Claim 19 words
A blood fractionation system as defined in claim 12 wherein said inlet and return pumps are each peristaltic-type pumps.
Claim 20
Dependent Claim 38 words
A blood fractionation system as defined in claim 12 wherein the volume of said first conduit is substantially equal to or greater than the volume of whole blood returned from said reservoir upon operation of said return pump.
Claim 21
Dependent Claim 49 words
A blood fractionation system as defined in claim 18 wherein said first conduit includes an in-line fluid mixing chamber upline of said filter having a volume substantially equal to or greater than the volume of whole blood returned from said reservoir upon a single operation of said return pump.
Claim 22
Dependent Claim 17 words
A blood fractionation system as defined in claim 12 wherein said filter is a membrane type filter.
Claim 23
Dependent Claim 18 words
A blood fractionation system as defined in claim 20 wherein said filter is a hollow fiber type filter.
Claim 24
Dependent Claim 24 words
A blood fractionation system as defined in claim 12 wherein said second fluid conduit means include a bubble trap and a fluid absence detector.
Claim 25
Dependent Claim 16 words
A blood fractionation system as defined in claim 12 wherein said separated blood fraction comprises plasma.
Claim 26
Dependent Claim 289 words
A single needle blood fractionation system for separating a blood fraction from whole blood, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle and alternately operable in forward and reverse flow for alternately receiving and returning blood from a donor; an intermediate fluid reservoir; j means including a first conduit connecting said donor conduit to said intermediate fluid reservoir; means including a flow-through filter disposed in said first conduit for separating the desired blood fraction from whole blood flowing through said filter; means including a second conduit conneeting said intermediate fluid reservoir and said donor interface conduit; an inlet pump for pumping fluid through said first conduit to said reservoir; a return pump for pumping fluid from said intermediate reservoir through said second conduit; system control means responsive to the volume of fluid in said intermediate reservoir for initiating operation of said return pump in response to said volume reaching a predetermined minimum level, thereby causing a predetermined volume of filtered fraction-depleted blood to be pumped from said intermediate reservoir; the rate of said return pump being adjustable relative to the rate of said inlet pump whereby upon operation of said return pump an operator selectable portion of the filtered blood in said second conduit is caused to recirculate through said first conduit and said filter; and means including an inline mixing chamber disposed in said first conduit upline of said filter and having a volume substantially equal to or greater than said predetermined volume of filtered blood pumped from said intermediate reservoir whereby the portion of said pumped filtered blood advanced through said first conduit is mixed with blood previously advanced in said first conduit prior to initiating operation of said return pump.
Claim 27
Dependent Claim 289 words
A single needle blood fractionation system for separating a blood fraction from whole blood, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle and alternately operable in forward and reverse flow for alternately receiving and returning blood from a donor; an intermediate fluid reservoir; j means including a first conduit connecting said donor conduit to said intermediate fluid reservoir; means including a flow-through filter disposed in said first conduit for separating the desired blood fraction from whole blood flowing through said filter; means including a second conduit conneeting said intermediate fluid reservoir and said donor interface conduit; an inlet pump for pumping fluid through said first conduit to said reservoir; a return pump for pumping fluid from said intermediate reservoir through said second conduit; system control means responsive to the volume of fluid in said intermediate reservoir for initiating operation of said return pump in response to said volume reaching a predetermined minimum level, thereby causing a predetermined volume of filtered fraction-depleted blood to be pumped from said intermediate reservoir; the rate of said return pump being adjustable relative to the rate of said inlet pump whereby upon operation of said return pump an operator selectable portion of the filtered blood in said second conduit is caused to recirculate through said first conduit and said filter; and means including an inline mixing chamber disposed in said first conduit upline of said filter and having a volume substantially equal to or greater than said predetermined volume of filtered blood pumped from said intermediate reservoir whereby the portion of said pumped filtered blood advanced through said first conduit is mixed with blood previously advanced in said first conduit prior to initiating operation of said return pump.
Claim 28
Dependent Claim 187 words
A blood fractionation apparatus for use in conjunction with a fluid flow system having a phlebotomy needle, a flow-through filter, an intermediate fluid reservoir, a first fluid conduit connecting the phlebotomy needle, filter and reservoir, and a second fluid conduit connecting the reservoir and the phlebotomy needle, comprising: an inlet pump for pumping whole blood from the phlebotomy needle through the filter to the reservoir; a return pump for pumping fluid from the reservoir to the phlebotomy needle; system control means responsive to the volume of fluid in the reservoir for initiating operation of said return pump upon filtered fluid in the reservoir reaching a maximum predetermined level, and for terminating operation of said return pump upon the fluid reaching a predetermined minimum volume; and the rate of said return pump being adjustable relative to the rate of said inlet pump whereby upon operation of said return pump an operator-selectable portion of the output of said return pump is caused to recirculate through said inlet pump and said filter and the remaining portion of said output is caused to be returned through the phlebotomy needle to the'donor.
Claim 29
Dependent Claim 187 words
A blood fractionation apparatus for use in conjunction with a fluid flow system having a phlebotomy needle, a flow-through filter, an intermediate fluid reservoir, a first fluid conduit connecting the phlebotomy needle, filter and reservoir, and a second fluid conduit connecting the reservoir and the phlebotomy needle, comprising: an inlet pump for pumping whole blood from the phlebotomy needle through the filter to the reservoir; a return pump for pumping fluid from the reservoir to the phlebotomy needle; system control means responsive to the volume of fluid in the reservoir for initiating operation of said return pump upon filtered fluid in the reservoir reaching a maximum predetermined level, and for terminating operation of said return pump upon the fluid reaching a predetermined minimum volume; and the rate of said return pump being adjustable relative to the rate of said inlet pump whereby upon operation of said return pump an operator-selectable portion of the output of said return pump is caused to recirculate through said inlet pump and said filter and the remaining portion of said output is caused to be returned through the phlebotomy needle to the'donor.
Claim 30
Dependent Claim 22 words
A blood fractionation apparatus as defined in claim 25 wherein said system control means are responsive to the weight of said reservoir.
Claim 31
Dependent Claim 31 words
A blood fractionation a-paratus as defined in claim 26 wherein said system control means include an electrical weight transducer providing an output signal indicative of the weight of the intermediate reservoir.
Claim 32
Dependent Claim 22 words
A blood fractionation apparatus as defined in claim 25 wherein said inlet pump and said return pump each comprise positive displacement pumps.
Claim 33
Dependent Claim 19 words
A blood fractionation apparatus as defined in claim 28 wherein said inlet and return pumps each comprise peristaltic-type pumps.
Claim 34
Dependent Claim 221 words
A disposable flow system for performing a blood fractionation procedure in conjunction with blood fractionation apparatus of the type having an inlet pump, a return pump, and system control means responsive to the volume of fluid in an associated fluid reservoir for initiating operation of said return pump in response to said volume reaching a predetermined maximum leve, and for terminating operation of said return pump upon said volume reaching a predetermined minimum level, the rate of the return pump being adjustable relative to the rate of the inlet pump, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle and alternately operable in forward and reverse flow for alternately receiving and returning blood from a donor; an intermediate fluid reservoir; means including a first conduit connecting said donor conduit to said intermediate fluid reservoir; means including a flow-through filter disposed in said first conduit for separating the desired blood fraction from whole blood flowing through said filter; means including a second conduit connecting said intermediate fluid reservoir and said donor interface conduit; and said intermediate fluid reservoir being adapted for association with said system control means, whereby upon operation of said return pump an operator selected portion of the filtered blood in said second conduit is caused to recirculate through said first conduit and said filter.
Claim 35
Dependent Claim 221 words
A disposable flow system for performing a blood fractionation procedure in conjunction with blood fractionation apparatus of the type having an inlet pump, a return pump, and system control means responsive to the volume of fluid in an associated fluid reservoir for initiating operation of said return pump in response to said volume reaching a predetermined maximum leve, and for terminating operation of said return pump upon said volume reaching a predetermined minimum level, the rate of the return pump being adjustable relative to the rate of the inlet pump, comprising: means including a donor interface conduit adapted for connection to a phlebotomy needle and alternately operable in forward and reverse flow for alternately receiving and returning blood from a donor; an intermediate fluid reservoir; means including a first conduit connecting said donor conduit to said intermediate fluid reservoir; means including a flow-through filter disposed in said first conduit for separating the desired blood fraction from whole blood flowing through said filter; means including a second conduit connecting said intermediate fluid reservoir and said donor interface conduit; and said intermediate fluid reservoir being adapted for association with said system control means, whereby upon operation of said return pump an operator selected portion of the filtered blood in said second conduit is caused to recirculate through said first conduit and said filter.
Claim 36
Dependent Claim 39 words
A disposable flow system as defined in claim 30 wherein the volume of said first conduit is substantially equal to or greater than the volume of whole blood returned from said reservoir upon operation of said return pump. :
Claim 37
Dependent Claim 49 words
A disposable flow system as defined in claim 31 wherein said first conduit includes an in-line fluid mixing chamber upline of said filter having a volume substantially equal to or greater than the volume of whole blood returned from said reservoir upon a single operation of said return pump.
Claim 38
Dependent Claim 17 words
A disposable flow system as defined in claim 30 wherein said filter is a membrane type filter.
Claim 39
Dependent Claim 18 words
A disposable flow system as defined in claim 33 wherein said filter is a hollow fiber type filter.
Claim 40
Dependent Claim 18 words
A disposable flow system as defined in claim 30 wherein said second fluid conduit includes a bubble trap.
Claim 41
Dependent Claim 117 words
A blood fractionation system comprising: a donor conduit for drawing and returning whole blood to a donor; flow-through separation means for separating a desired blood fraction from whole blood; a fluid reservoir; a first fluid conduit connecting said donor conduit assembly, said separation means and said reservoir; a second fluid conduit connecting said-reservoir and said donor conduit; inlet pump means for pumping fluid along said first conduit; return pump means for pumping fluid along said second conduit; and system control means responsive to the volume of fluid in said reservoir for rendering said return pump operative upon said reservoir volume exceeding a predetermined maximum level, and inoperative upon said reservoir volume falling below a predetermined minimum level.
Claim 42
Dependent Claim 117 words
A blood fractionation system comprising: a donor conduit for drawing and returning whole blood to a donor; flow-through separation means for separating a desired blood fraction from whole blood; a fluid reservoir; a first fluid conduit connecting said donor conduit assembly, said separation means and said reservoir; a second fluid conduit connecting said-reservoir and said donor conduit; inlet pump means for pumping fluid along said first conduit; return pump means for pumping fluid along said second conduit; and system control means responsive to the volume of fluid in said reservoir for rendering said return pump operative upon said reservoir volume exceeding a predetermined maximum level, and inoperative upon said reservoir volume falling below a predetermined minimum level.
Claim 43
Dependent Claim 48 words
A blood fractionation system as defined in claim 36 wherein said second pump means is operator-adjustable relative to said first pump means whereby upon operation of said second pump means a selected portion of the whole blood from said reservoir is caused to recirculate through said separation means.
Claim 44
Dependent Claim 24 words
A blood fractionation system as defined in claim 36 wherein said second fluid conveyance means are responsive to the weight of said intermediate reservoir.
Claim 45
Dependent Claim 20 words
A blood fractionation system as defined in claim 36 wherein the rates of said inlet and return pumps are operator-adjustable.
Claim 46
Dependent Claim 38 words
A blood fractionation system as defined in claim 36 wherein the volume of said first conduit is substantially equal to or greater than the volume of whole blood returned from said reservoir upon operation of said return pump.
Claim 47
Dependent Claim 50 words
A blood fractionation system as defined in claim 40 wherein said first conduit includes an in-line fluid mixing chamber upline of said separation means having a volume substantially equal to or greater than the volume of whole blood returned from said reservoir upon a single operation of said return pump.
Claim 48
Dependent Claim 23 words
A blood fractionation system as defined in claim 36 wherein said second fluid conveyance means include a bubble trap and fluid absence detector.
Claim 49
Dependent Claim 18 words
A blood fractionation system as defined in claim 36 wherein said separation means comprise a membrane type filter.
Claim 50
Dependent Claim 19 words
A blood fractionation system as defined in claim 43 wherein said membrane type filter is a hollow-fiber type filter.
Claim 51
Dependent Claim 95 words
A blood fractionation system for separating whole blood into cellular and non-cellular components, and collecting the components, wherein whole blood is alternately drawn and returned relative to a donor through a phlebotomy needle, said system comprising: means for monitoring the volume of the separated cellular component; and control means for commencing return of the separated cellular component to the donor when the volume of the collected cellular component reaches a predetermined maximum level, and for terminating the return of the cellular component when the volume of the collected cellular component reaches a predetermined minimum level.
Claim 52
Dependent Claim 95 words
A blood fractionation system for separating whole blood into cellular and non-cellular components, and collecting the components, wherein whole blood is alternately drawn and returned relative to a donor through a phlebotomy needle, said system comprising: means for monitoring the volume of the separated cellular component; and control means for commencing return of the separated cellular component to the donor when the volume of the collected cellular component reaches a predetermined maximum level, and for terminating the return of the cellular component when the volume of the collected cellular component reaches a predetermined minimum level.
Claim 53
Dependent Claim 23 words
A blood fractionation system as defined in claim 45 wherein said control means are responsive to the weight of the separated cellular component.
Claim 54
Dependent Claim 31 words
A blood fractionation system as defined in claim 46 wherein said control means include an electrical weight transducer providing an output signal indicative of the weight of the separated cellular component.
Claim 55
Independent Claim 112 words
The method of separating a blood component from whole blood, utilizing a phlebotomy needle, and flow-through separating means, comprising the steps of: pumping in whole blood drawn through the needle through the separation means; collecting the component-deficient blood from the separation means in a reservoir; initiating pumping back component-deficient blood from the reservoir to the needle upon the volume of blood in the reservoir rising above a predetermined level; said pumping back being at a higher rate than said pumping in whereby the volume of blood in the reservoir is caused to diminish; and terminating pumping back from said reservoir upon the volume in the reservoir falling below a predetermined minimum level.
Claim 56
Independent Claim 112 words
The method of separating a blood component from whole blood, utilizing a phlebotomy needle, and flow-through separating means, comprising the steps of: pumping in whole blood drawn through the needle through the separation means; collecting the component-deficient blood from the separation means in a reservoir; initiating pumping back component-deficient blood from the reservoir to the needle upon the volume of blood in the reservoir rising above a predetermined level; said pumping back being at a higher rate than said pumping in whereby the volume of blood in the reservoir is caused to diminish; and terminating pumping back from said reservoir upon the volume in the reservoir falling below a predetermined minimum level.
Claim 57
Dependent Claim 19 words
The method of blood fractionation described in claim 48 wherein said pumping in is continued during said pumping back.
Claim 58
Dependent Claim 33 words
The method of blood fractionation described in claim 49 including the additional step of adjusting the rate of pumping in to the rate of pumping back to establish recirculation through said separation means.

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